Approved Research This page provides a searchable list of all research protocols that have been reviewed and approved by the Uganda National Council for Science and Technology(UNCST).
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Name Title Nationality Approval Date Expiry Date Field of Science/Classification Trial Type Research Type  
Victoria Nankabirwa
ID: UNCST-2021-R011871
Implementation of an eRegistry Enabled Transition from Four to Eight Antenatal Care Contacts - a Cluster-Randomized Controlled Trial in Mukono and Buikwe, Uganda (eReg4ANC8)
REFNo: HS2662ES

III. Undertake a cRCT of the new ANC8 vs. the current ANC4 schedule for low-risk pregnancies, to estimate its impact on quality of care, health, and satisfaction.,II. To assess and respond to factors across the i-PARIHS and COM-B domains to guide the facilitation of feasibility, acceptability, fidelity, and effectiveness of implementation of digitally enabled ANC8 at scale. ,I. To assess and respond to factors across the PARIHS and COM-B domains to guide the facilitation of feasibility, acceptability, fidelity, and effectiveness of the implementation of DHIS2 eRegistries for ANC at scale. ,
Uganda 2023-03-16 13:01:11 2026-03-16 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Victoria Ndyanabangi
ID: UNCST-2021-R012645
IMPAACT 2036: Phase I/II Study of the Safety, Tolerability,Acceptability, and Pharmacokinetics of Oral and Long-ActingInjectable Cabotegravir and Rilpivirine in Virologically SuppressedChildren Living with HIV-1, Two to Less Than 12 Years of Age, DAIDSStudy ID #38932 IND # 138754
REFNo: HS2688ES

To propose the weight band dosing of oral cabotegravir (CAB) + oral rilpivirine (RPV)followed by long-acting injectable CAB (CAB LA) + long-acting injectable RPV (RPV LA)in children living with HIV-1, and to describe participant choice and experience with theregimen with or without an oral lead-in period.
To describe the repeat-dose pharmacokinetics of CAB + RPV (oral and injectable)through Week 24
To assess the safety of the oral lead-in of CAB + RPV, and the safety of CAB + RPV (oraland injectable) through Week 24
To assess the safety of CAB + RPV (oral and injectable) through Weeks 48 and 72
To describe the repeat-dose pharmacokinetics of injectable CAB LA + RPV LA throughWeeks 48 and 72
To assess the maintenance of viral suppression of CAB + RPV (oral and injectable)through Weeks 24, 48, and 72
To evaluate the tolerability and acceptability of injectable CAB LA + RPV LA throughWeeks 24, 48, and 72
To describe HIV-1 genotypes and phenotypes for children who experience virologicfailure during study treatment
To assess immunologic activity of CAB + RPV (oral and injectable) through Weeks 24,48, and 72
To describe tolerability and acceptability of 48 weeks of CAB + RPV (oral and injectable)and 44 weeks of CAB LA + RPV LA (injectable only)
To describe the safety and repeat-dose pharmacokinetics of 48 weeks of CAB + RPV(oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only)
To describe the maintenance of viral suppression and immunologic activity of 48 weeks ofCAB + RPV (oral and injectable) or 44 weeks of CAB LA + RPV LA (injectable only)
To describe HIV-1 genotypes and phenotypes for children who experience virologicfailure during 48 weeks of CAB + RPV (oral and injectable) or during 44 weeks of CABLA + RPV LA (injectable only)
To characterize long-term safety and washout PK through 48 weeks after permanentdiscontinuation of injectable CAB LA + RPV LAV LA
To characterize PK of CAB + RPV oral formulations when dispersed in liquid vs. directly ingested (Weight Bands 3, 4 and 5)
Uganda 2023-03-16 12:55:20 2026-03-16 Medical and Health Sciences Clinical Trial Non-degree Award
Charles Batte
ID: UNCST-2021-R013587
The impact of COVID-19 on school enrolment and mental health of children in the Manafwa Watershed area in Uganda.
REFNo: HS2725ES

To assess the coping strategies of school-going children in the Manafwa Watershed area during the COVID-19 pandemic.,To assess the post-lockdown mental health status of school-going children in the Manafwa Watershed area. ,To evaluate the effects of COVID-19 lockdown on school enrolment of children in the Manafwa Watershed area.,To assess the impact of COVID-19 and its associated restrictive measures on school enrolment and mental health of children in a disaster-prone area, Manafwa Watershed area, in Eastern Uganda.,
Uganda 2023-03-16 12:51:27 2026-03-16 Medical and Health Sciences Non-Clinical Trial Non-degree Award
Jack Richardson Lloyd
ID:
The role of social play in the development of wild mountain gorillas in Bwindi Impenetrable National Park, Uganda
REFNo: NS490ES

(1) determine how biological, ecological, and social factors influence amount of time spent in social play.
(2) examine how structural components of play (asymmetry, dominance, play
partnerships, play type) can differentiate between functions.
(3) investigate proposed trade-offs and developmental outcomes of social play.
UK 2023-03-16 12:48:10 2026-03-16 Natural Sciences Non-Clinical Trial Degree Award
Peter Elyanu James
ID: UNCST-2021-R013210
GS-US-380-1474: A Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose Combination (FDC) in HIV-1 Infected Adolescents and Children
REFNo: HS2708ES

This is a multisite, multi-cohort study that aims to recruit subjects in four weight-based cohorts (i.e. Cohort 1, 2, 3 and 4), with each cohort having specific objectives aligned with it. Baylor Uganda site will recruit subjects in cohort 4 with is further subdivided in 4 weight-based sub-groups. The study objectives in relation to the Cohort 4 are as follows;
Cohort 4
Group 1:
The primary objective of this study is:
• To evaluate the safety and tolerability of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Week 24 in HIV-1 infected, virologically suppressed children ? 2 years of age weighing ? 14 to < 25 kg who are unable to swallow tablets
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Week 48 in HIV-1 infected, virologically suppressed children ? 2 years of age weighing ? 14 to < 25 kg who are unable to swallow tablets

• To evaluate the antiviral activity of B/F/TAF 30/120/15 mg (administration of 2 B/F/TAF 15/60/7.5 mg FDC TOS) once daily through Weeks 24 and 48 in HIV-1 infected, virologically suppressed children ? 2 years of age weighing ? 14 to < 25 kg who are unable to swallow tablets
Group 2:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily in HIV-1 infected children ? 1 month of age, on ARV treatment or treatment naive, weighing ? 10 to < 14 kg

• To evaluate the safety and tolerability of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ? 1 month of age, on ARV treatment or treatment naive, weighing ? 10 to < 14 kg
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ? 1 month of age, on ARV treatment or treatment naive, weighing ? 10 to < 14 kg

• To evaluate the antiviral activity of B/F/TAF 7.5/30/3.75 mg (administration of 2 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ? 1 month of age, on ARV treatment or treatment naive, weighing ? 10 to < 14 kg.
Group 3:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily in HIV-1 infected children ? 1 month of age, on ARV treatment or treatment naive, weighing ? 6 to < 10 kg

• To evaluate the safety and tolerability of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ? 1 month of age, on ARV treatment or treatment naive, weighing ? 6 to < 10 kg.
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 3.75/15/1.88 mg (administration of 1 B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ? 1 month of age, on ARV treatment or treatment naive, weighing ? 6 to < 10 kg

• To evaluate the antiviral activity of B/F/TAF 3.75/15/1.88 mg (administration of 1 × B/F/TAF 3.75/15/1.88 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ? 1 month of age, on ARV treatment or treatment naive, weighing ? 6 to < 10 kg.
Group 4:
The primary objectives of this study are:
• To evaluate the steady state PK of BIC and TAF and confirm the dose of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily in HIV-1 infected children ? 1 month of age, on ARV treatment or treatment naive, weighing ? 3 to < 6 kg.

• To evaluate the safety and tolerability of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Week 24 in HIV-1 infected children ? 1 month of age, on ARV treatment or treatment naive, weighing ? 3 to < 6 kg
The secondary objectives of this study are:
• To evaluate the safety and tolerability of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Week 48 in HIV-1 infected children ? 1 month of age, on ARV treatment or treatment naive, weighing ? 3 to < 6 kg

• To evaluate the antiviral activity of B/F/TAF 1.88/7.5/0.94 mg (administration of 1 B/F/TAF 1.88/7.5/0.94 mg FDC TOS) twice daily through Weeks 24 and 48 in HIV-1 infected children ? 1 month of age, on ARV treatment or treatment naive, weighing ? 3 to < 6 kg

Uganda 2023-03-16 12:47:17 2026-03-16 Medical and Health Sciences Clinical Trial Non-degree Award
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